olmesartan medoxomil-hydrochlorothiazide (42291-924)

Drug Facts

Product Profile

Brand Name olmesartan medoxomil-hydrochlorothiazide

Generic Name olmesartan medoxomil-hydrochlorothiazide

Labeler avkare

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

hydrochlorothiazide 12.5 mg/1, olmesartan medoxomil 20 mg/1

Manufacturer

AvKARE

Identifiers & Regulatory

Product NDC 42291-924

Product ID 42291-924_48bfa982-5678-139d-e063-6294a90adbfa

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA021532

Listing Expiration 2027-12-31

Marketing Start 2023-07-27

Pharmacologic Class

Established (EPC)

thiazide diuretic [epc]

Chemical Structure

thiazides [cs]

Physiologic Effect

increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291924

Hyphenated Format 42291-924

Supplemental Identifiers

RxCUI

403853 403854 403855

UPC

0342291925908 0342291924901

UNII

0J48LPH2TH 6M97XTV3HD

NUI

N0000175359 N0000175419 M0471776

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olmesartan medoxomil-hydrochlorothiazide (source: ndc)

Generic Name olmesartan medoxomil-hydrochlorothiazide (source: ndc)

Application Number NDA021532 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

12.5 mg/1
20 mg/1

source: ndc

Packaging

90 TABLET, FILM COATED in 1 BOTTLE (42291-924-90)

source: ndc

Packages (1)

42291-924-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-924-90)

Ingredients (2)

hydrochlorothiazide (12.5 mg/1) olmesartan medoxomil (20 mg/1)

Linked Drug Pages (1)

olmesartan medoxomil-hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "48bfa982-5678-139d-e063-6294a90adbfa", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0342291925908", "0342291924901"], "unii": ["0J48LPH2TH", "6M97XTV3HD"], "rxcui": ["403853", "403854", "403855"], "spl_set_id": ["017bc6a3-5b3d-2381-e063-6394a90abece"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-924-90)", "package_ndc": "42291-924-90", "marketing_start_date": "20230727"}], "brand_name": "olmesartan medoxomil-hydrochlorothiazide", "product_id": "42291-924_48bfa982-5678-139d-e063-6294a90adbfa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "42291-924", "generic_name": "olmesartan medoxomil-hydrochlorothiazide", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "olmesartan medoxomil-hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "12.5 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "20 mg/1"}], "application_number": "NDA021532", "marketing_category": "NDA", "marketing_start_date": "20230727", "listing_expiration_date": "20271231"}